EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission [Yahoo! Finance]
NeuroSense Therapeutics Ltd. (NRSN)
Company Research
Source: Yahoo! Finance
3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS) ALS is a fatal type of motor neuron disease. It causes progressive degeneration of nerve cells in the spinal cord and brain. The FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements. NeuroSense plans to give an update on the meeting results following receipt of the meeting minutes, which are expected approximately one month after the meeting. PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in clinical and biological markers of disease progression In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, wit
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NRSN
News
- NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MND [Yahoo! Finance]Yahoo! Finance
- NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MNDPR Newswire
- NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA SubmissionPR Newswire
- New Analysis Shows PrimeC Significantly Improves Key miRNAs in ALS PatientsPR Newswire
- NeuroSense Advances Plans for Early Commercialization of Groundbreaking ALS Treatment in Canada, Provides Further UpdatesPR Newswire
NRSN
Sec Filings
- 11/19/24 - Form F-1
- 11/12/24 - Form 6-K
- 10/31/24 - Form 6-K
- NRSN's page on the SEC website